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Letermovir for CMV Prevention in Pediatric Kidney Transplant Patients

This study is looking at a medication called letermovir in children and adolescents who have received a kidney transplant. The goal is to see how the body handles letermovir over time and to check if it's safe and well-tolerated. You might be able to join if you are under 18, have had a kidney transplant between 4 weeks and 52 weeks ago, have stable kidney function, and do not have cytomegalovirus (CMV), a common virus that can cause problems after transplant. Researchers plan to enroll 40 participants. The study will measure the amount of letermovir in the body over 24 hours on Day 7 of treatment.

Study design
This interventional study plans to enroll 40 participants. The phase of the study is not specified.
What's involved
Participants will receive letermovir orally or through a tube for 7 consecutive days. Blood samples will be taken on Day 7 to measure drug levels.
Compensation
Not stated in the trial record.
Follow-up
Drug levels will be measured up to 24 hours after the last dose on Day 7.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07199465

A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)

Recruiting
PHASE1Up to 17InterventionalTreatment
Merck Sharp & Dohme LLC
~40 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Letermovir

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area Under the Curve From Time 0 to 24 Hours (AUC0-24)
Measured over Day 7: Predose and at designated timepoints post-dose (up to 24 hours)

Conditions

Cytomegalovirus Prophylaxis

Explore related trials

Cytomegaloviral InfectionCytomegaloviral Infection

NCT07199465

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0004)

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • Children's Healthcare of Atlanta-Center for Advanced Pediatrics ( Site 0020)

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Children's Hospital Colorado ( Site 0013)

    Aurora, Coloradostudy coordinator listed

    Recruiting

  • Children's Hospital Los Angeles ( Site 0016)

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Children's Hospital of Philadelphia (CHOP) ( Site 0003)

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Children's Hospital of Pittsburgh - Department of Pediatrics ( Site 0011)

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

  • Cincinnati Children's Hospital Medical Center ( Site 0002)

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

  • Duke University-Pediatrics ( Site 0008)

    Durham, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Eligibility criteria

Inclusion

Is a recipient of a primary or secondary allograft kidney
Is at least 4 weeks posttransplant and not more than 52 weeks posttransplant at the time of enrollment (Day 1) and is being managed per local standard of care
Has stable kidney function posttransplant
Has undetectable CMV deoxyribonucleic acid (DNA) from a plasma or whole blood sample collected within 14 days prior to enrollment
Must be able to take (as assessed by the investigator) letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube (oral pellets only)
Does not have a condition that may interfere with the absorption of oral medication (e.g., vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment (Day 1) until the intensive pharmacokinetics (IPK) sampling is completed
Weighs ≥2.5 and \<40 kg at enrollment (Day 1)

Exclusion

Has CMV disease or suspected CMV disease between screening and enrollment
Is on dialysis or plasmapheresis at the time of enrollment
Has evidence of CMV viremia at any time from screening until the time of enrollment
Has Child-Pugh B or C hepatic insufficiency within 14 days before enrollment
Is a multi-organ transplant recipient (e.g., kidney-pancreas)
Has any uncontrolled infection on the day of enrollment
Requires mechanical ventilation, or is hemodynamically unstable, at the time of enrollment
Has received or is receiving protocol-specified prohibited medications

What this trial measures

  • Area Under the Curve From Time 0 to 24 Hours (AUC0-24)Day 7: Predose and at designated timepoints post-dose (up to 24 hours)

    Blood samples will be collected at multiple time points to estimate AUC0-24